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PREGNANCY AND INFANT OUTCOMES FOLLOWING IN UTERO EXPOSURE TO JAK INHIBITORS IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A GLOBAL MULTICENTER COHORT STUDY

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PREGNANCY AND INFANT OUTCOMES FOLLOWING IN UTERO EXPOSURE TO JAK INHIBITORS IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A GLOBAL MULTICENTER COHORT STUDY

Mette Julsgaard 1,2, Simon Mark Dahl Baunwall 1, Cynthia Seow 3, Dana Duricova 4, Sunanda Kane 5, Neha Zacharias 6, Rupert W Leong 7,8, Bel Klaartje Kok 9, Anna Kagramanova 10,11, Barbora Pipek 12,13, Kristina Candido 14, Rachel Cooney 15, Rafal Filip 16,17, Vytautas Kiudelis 18, Michal Konecny 19, Daniela Pugliese 20,21, Genoile Silva 22, Edoardo Vincenzo Savarino 23, Brigita Smolovic 24, Sophie Vieujean 25, Shu-Chen Wei 26, Uma Mahadevan 27

Affiliations

1 Aarhus University Hospital, Aarhus N, Denmark

2 Aarhus University, Aarhus N, Denmark

3 University of Calgary, Calgary, Canada

4 ISCARE I.V.F. a.s., Prague, Czechia

5 Mayo Clinic, Rochester, Rochester, United States

6 Hull University Teaching Hospitals, Hull, United Kingdom

7 Concord Repatriation General Hospital, Sydney, Australia

8 Macquarie University, Sydney, Australia

9 Barts Health NHS Trust, London, United Kingdom

10 A. S. Loginov Moscow Clinical Scientific Center, Moscow, Balaschiha, Russian Federation

11 Research Institute of Health Organization and Medical Management, Moscow, Russian Federation

12 Faculty of Medicine and Dentistry, Palacky University and University Hospital, Olomouc, Czechia

13 Hospital AGEL Vitkovice, Ostrava, Czechia

14 McGill University, Montreal, Canada

15 University Hospital Birmingham NHS Trust, Birmingham, United Kingdom

16 Regional Hospital No. 2 in Rzeszow, Rzeszów, Poland

17 University of Rzeszow, Rzeszow, Poland

18 Lithuanian University of Health Sciences, Kaunas, Lithuania

19 Palacky University and University Hospital Olomouc, Olomouc, Czechia

20 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

21 Università Cattolica del Sacro Cuore, Rome, Italy

22 Universidade do Estado da Bahia, Salvador, Bahia, Brazil

23 University of Padua, Division of Gastroenterology, Padua, Italy

24 Faculty of Medicine, University of Montenegro, Podgorica, Montenegro

25 University Hospital CHU of Liège, Liège, Belgium

26 National Taiwan University Hospital, Taipei City, Taiwan, Province of China

27 University of California, San Francisco, United States

Summary

AI Generated

In a global multicenter retrospective study of 43 JAK inhibitor-exposed pregnancies in women with IBD, maternal complication rates were low and no congenital abnormalities were observed among 35 live births, with reassuring infant outcomes including normal development and no adverse vaccine responses.

Among 35 live births, no congenital abnormalities were reported, with 1 preterm infant (2.9%), 3 small for gestational age (8.6%), and 1 with Apgar score less than 7 at 5 minutes (2.9%).
Maternal complications were low with no cases of DVT or preeclampsia, though 3 cases of premature rupture of membranes (GA 34-37) and 4 hospitalizations for infection or other complications occurred.
Disease activity was present in 51.2% of pregnancies, and among women who discontinued JAK inhibitors in the first or second trimester, 63.6% experienced disease flare.
Follow-up of 31 infants (median 17 months, range 1-88) showed 100% normal development, with no adverse effects reported following live BCG, rotavirus, or MMR vaccines.
Two infants (6.5%) required hospitalization for infection at age 0-4 months, both born to mothers with moderate-to-severe disease activity treated with systemic corticosteroids and upadacitinib initiated during pregnancy, with no infection-related sequelae.
Among 24 breastfeeding women, 29.2% continued JAK inhibitor treatment during lactation.

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Abstract

Introduction

JAK inhibitors (JAKi) are small molecules capable of crossing the placenta via passive diffusion or active extracellular transport from early pregnancy.¹ Data on the risks of in utero JAKi exposure are limited,² particularly regarding pregnancy outcomes, infant infections, vaccine responses, and childhood development.

Aims & Methods

We conducted a multicenter retrospective JAKi and pregnancy observational study supported by the ECCO Collaborative Network for Exceptionally Rare Case Reports (CONFER). Pregnant women with inflammatory bowel disease (IBD) exposed to tofacitinib (TOFA), upadacitinib (UPA), or filgotinib (FILGO) during pregnancy were enrolled from 21 centers across 15 countries. Data collected included maternal demographics, IBD characteristics, disease activity, medication use - including timing and duration of JAKi exposure - along with maternal, pregnancy, and infant outcomes.

Results

Of 43 JAKi exposed pregnancies, 17 (39.5%) were unplanned. Disease activity was present in 22 (51.2%) of the pregnancies. One-in-five women initiated JAKi in pregnancy (n=8, 18.6%). Abortion occurred in 8 cases, at a median gestational age (GA) of 8.5 weeks (range 3-16). Of these, 3 (7.0%) were spontaneous and 5 (11.6%) induced, with two terminations due to concerns about potential adverse effects of JAKi treatment. Of the remaining 35 pregnancies 26 (74.3%) were exposed to TOFA (5 mg BID (n=9), 10 mg BID (n=17)), 8 (22.9%) to UPA (30 mg daily (n=2), 45 mg daily (n=6)) and one (2.9%) to FILGO (200 mg daily). The majority received JAKi treatment throughout pregnancy (n=24, 68.6%). Discontinuation of JAKi during the 1^st or 2^nd trimester was followed by disease activity in 7 of 11 cases (63.6%). Maternal complication risk was low: no cases of DVT or (pre)eclampsia; premature rupture of membranes (GA 34–37) occurred in 3 cases, and 4 women required hospitalization due to infection or other complications. Among 35 live births, one infant (2.9%) was preterm (GA 34), three (8.6%) were small for gestational age, one (2.9%) had an Apgar score <7 at 5 minutes, and no congenital abnormalities were reported. Follow-up infant data are shown in table 1. One-third of breastfeeding women continued JAKi treatment. A high adherence rate to the national immunization schedule was seen. Three (8.6%) skipped the live rotavirus vaccine due to in uteroJAKi exposure. No adverse effects were reported following live attenuated or inactivated vaccines, and no malignancies were observed.

Table 1. Follow-up in 31 infants after in utero exposure to JAK-inhibitors
	n	(%)	Notes
Duration, months – median (range)	17	(1-88)
Proportion of breastfeeding women (n=24) who continued JAKi treatment	7	(29.2)
Infection resulting in hospitalization (age 0-4 months)	2	(6.5)	Moderate-to-severe maternal disease activity treated with systemic corticosteroids and initiation of upadacitinib at gestational weeks 8 and 28, respectively. No infection-related sequelae.
Normal development	31	(100)
Follow the national immunization program	26	(74.3)
Live BCG vaccine provided (age 0-1 month)	5	(16.1)	No adverse effects reported.
Live Rotavirus vaccine provided (age 1.5-6 months)	13	(41.9)	No adverse effects reported.
Live MMR vaccine provided (age ≥ 12 months)	13	(41.9)	No adverse effects reported.

Conclusion

In this global multicenter study of JAKi exposure during pregnancy in women with IBD, maternal complication rates were low, and no increased risk of adverse pregnancy outcome were observed among live births. While disease activity was common, particularly following early discontinuation of JAKi, infant outcomes - including development, infection risk, and vaccine response - were reassuring. These findings provide important preliminary safety data to guide decision-making regarding the use of JAKi in pregnancy, though further prospective studies are needed to confirm long-term safety.

References

1. Fein KC, Arral ML, Kim JS, et al. Placental drug transport and fetal exposure during pregnancy is determined by drug molecular size, chemistry, and conformation. J Control Release 2023;361:29-39.
2. Torres J, Chaparro M, Julsgaard M, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis 2023;17:1-27.

Disclosure

M. Julsgaard: Advisory board for AbbVie. G. Santana: Speaker and advisory board for pfizer.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Clinical management of IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Peter Irving

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Appendectomy? The solution for ulcerative colitis

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Appendectomy? The solution for ulcerative colitis

Eva Visser 1

Affiliations

1 Amsterdam University Medical Centre, Amsterdam, Netherlands

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Paediatrics Surgery

Session

What's new in ulcerative colitis 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Peter Irving

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TRANSFORMING IUS INTERPRETATION: INTEGRATION OF AI MODELS IN INTESTINAL ULTRASOUND IMAGING

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TRANSFORMING IUS INTERPRETATION: INTEGRATION OF AI MODELS IN INTESTINAL ULTRASOUND IMAGING

Dan Carter 1, Gal Ashkenzai 2, Oshrit Hoffer 2

Affiliations

1 Sheba Medical Center, Ramat Gan, Israel

2 Afeka Colledge of Engineering, Tel Aviv, Israel

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Abstract

Introduction

Accurate diagnosis and monitoring of inflammatory bowel diseases (IBD) are essential for effective management and reduction of complications. Intestinal ultrasound (IUS) is a non-invasive and cost-effective imaging modality for IBD assessment, yet its widespread adoption is limited by operator dependency and interobserver variability. Artificial intelligence (AI) offers the potential to overcome these limitations by improving diagnostic accuracy and standardizing interpretation.

Aims & Methods

This study aimed to develop an AI-assisted model for the automatic detection of active inflammation in IUS images, using bowel wall thickness (BWT) as a key marker. We further aimed to create an automatic tool for detecting bowel segments within ultrasound images and to extend its application from single images to cine loops. Grayscale ultrasound images and cine-loops of the terminal ileum were collected from Crohn’s disease patients undergoing IUS at a tertiary center. The dataset included both normal and abnormal BWT and was annotated by an experienced operator. Preprocessing involved anonymization and normalization. Automated segmentation algorithms were used to isolate bowel wall structures, and deep learning techniques, including convolutional neural networks (CNNs) and YOLO (You Only Look Once) object detection, were employed to analyze the images.

Results

The study included 2,735 grayscale ultrasound images and cine-loops of the terminal ileum from patients with Crohn's disease. The dataset was divided into three sets: a training set of 1980 images, a validation set of 220 images, and a test set of 515 images. Our model achieved robust performance metrics, including sensitivity, specificity, and accuracy of 99.1%, 94.6%, and 91.5%, respectively, for BWT detection, with an area under the receiver operating characteristic curve (AUC) of 0.85. Our model was validated on 10 independent cine-loops, comprising 7 abnormal and 3 normal cases. It accurately identified bowel wall thickening (BWT) in all seven abnormal cases, correctly classifying them as abnormal. Additionally, the model successfully confirmed the absence of BWT in all three normal cine-loops, categorizing them appropriately as normal.

Conclusion

This study represents a significant advancement in the application of artificial intelligence to intestinal ultrasound interpretation by integrating automated segmentation, automatic analysis capabilities, and cine-loop evaluation. Our model extends beyond traditional static image analysis, paving the way for real-time and dynamic assessments of bowel inflammation. This approach highlights the potential of our AI tools to reduce operator dependency, improve diagnostic accuracy, and enhance clinical workflows, making IUS more accessible and reliable for clinicians with varying levels of expertise.

Disclosure

Prof. Dan Carter has received speaker’s fees, research support, or consultancy fees from Takeda, Janssen, AbbVie, and Taro

Event

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Artificial intelligence in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Peter Irving

UEG Presentation

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MICROPLASTIC-INDUCED ALTERATIONS IN GUT MICROBIOME AND METABOLISM: INSIGHTS FROM AN EX VIVO BIOREACTOR MODEL

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MICROPLASTIC-INDUCED ALTERATIONS IN GUT MICROBIOME AND METABOLISM: INSIGHTS FROM AN EX VIVO BIOREACTOR MODEL

Christian Pacher-Deutsch 1,2, Kristina Žukauskaitė 1,2, Cigdem Akar 2, Maximilian Nepel 2, Lukas Kogler 1,3,4, Hansjörg Habisch 2, Serena Ducoli 5, Stefania Federici 5, Tobias Madl 2,6, Verena Pichler 1,3, Angela Horvath 1,2, Vanessa Stadlbauer 1,2,6

Affiliations

1 Center for Biomarker Research in Medicine (CBmed), Graz, Austria

2 Medical University of Graz, Graz, Austria

3 University of Vienna, Vienna, Austria

4 Medical University of Vienna, Vienna, Austria

5 University of Brescia, Brescia, Italy

6 BioTechMed-Graz, Graz, Austria

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Abstract

Introduction

Microplastic particles (MPs), defined as plastic fragments smaller than 5 mm, are pervasive pollutants that accumulate in ecosystems and the human food chain (1). Literature points at various health risks, including the induction of carcinogenesis (2). Emerging evidence from animal models (3) suggests that MPs may influence the gut microbiome, but the impact on the human gut microbiome remains poorly understood.

Aims & Methods

This study aimed to evaluate how various MP types influence gut microbial composition and metabolism using an ex vivo bioreactor model, with a focus on exploring potential carcinogenic effects arising from MP–microbiome interactions.
Stool samples from healthy donors were used to inoculate bioreactor cultures, which were maintained under anaerobic conditions for five days with daily nutrient feeding. These cultures were exposed to five common MP types—polystyrene (PS), polypropylene (PP), low-density polyethylene (LDPE), poly(methyl methacrylate) (PMMA), and polyethylene terephthalate (PET)—at concentrations mimicking both estimated human exposure (4) and higher doses to assess dose-dependence. Cell viability and total bacterial counts, as well as culture pH, were measured throughout the experiment. To further explore potential microbiome and metabolic alterations, 16S rRNA gene sequencing and targeted metabolomics were performed.

Results

MP exposure did not lead to significant changes in total or viable bacterial cell counts. However, MP-treated cultures exhibited a consistent and significant decrease in pH compared to controls, suggesting changes in microbial metabolic activity. Microbiome sequencing revealed plastic-type-dependent alterations in microbial composition, with certain bacterial taxa increasing or decreasing in abundance depending on the MP type. These shifts occurred across multiple genera within diverse families, including Lachnospiraceae, Oscillospiraceae, Enterobacteriaceae, and Ruminococcaceae, with the majority of changes occurring withing the phylum Bacillota. These compositional changes were accompanied by shifts in the metabolomic profiles, some of which correlated with the observed pH changes. Several plastic types induced changes in valeric acid levels, while individual MP types were associated with alterations in distinct metabolites such as uracil, lactic acid, and acetic acid.

Conclusion

This study demonstrates that MPs can affect gut microbial activity and metabolism without significantly altering overall bacterial abundance in the short term. The variation in microbiome response across plastic types highlights the complexity of MP-microbiome interactions. Changes in faecal pH are known to be associated with various gastrointestinal diseases (5). Interestingly, some of the MP-induced changes in microbial composition resembled patterns linked to diseases such as depression and colorectal cancer. In contrast, other changes showed patterns that differed from those typically associated with conditions like Parkinson’s disease and irritable bowel syndrome, highlighting the complexity of these associations and the dependency on the context. The bioreactor model provided a controlled environment for identifying direct MP-microbiome interactions; however, in humans, additional factors like diet, immune response, and individual microbiome variations play a role in determining long-term effects. Exposure duration may also play a critical role in shaping the extent and nature of microbiome alterations (6), underscoring the need for further research into the effects of chronic MP exposure and associated health risks.

References

(1) Mamun, A. A., Prasetya, T. A. E., Dewi, I. R., & Ahmad, M. (2023). Microplastics in human food chains: Food becoming a threat to health safety. The Science of the total environment, 858(Pt 1), 159834. https://doi.org/10.1016/j.scitotenv.2022.159834
(2) Kumar, R., Manna, C., Padha, S., Verma, A., Sharma, P., Dhar, A., Ghosh, A., & Bhattacharya, P. (2022). Micro(nano)plastics pollution and human health: How plastics can induce carcinogenesis to humans?. Chemosphere, 298, 134267. https://doi.org/10.1016/j.chemosphere.2022.134267
(3) Hirt, N., & Body-Malapel, M. (2020). Immunotoxicity and intestinal effects of nano- and microplastics: a review of the literature. Particle and fibre toxicology, 17(1), 57. https://doi.org/10.1186/s12989-020-00387-7
(4) Senathirajah, K., Attwood, S., Bhagwat, G., Carbery, M., Wilson, S., & Palanisami, T. (2021). Estimation of the mass of microplastics ingested - A pivotal first step towards human health risk assessment. Journal of hazardous materials, 404(Pt B), 124004. https://doi.org/10.1016/j.jhazmat.2020.124004
(5) Yamamura, R., Inoue, K. Y., Nishino, K., & Yamasaki, S. (2023). Intestinal and fecal pH in human health. Frontiers in Microbiomes, 2, 1192316.
(6) Yin, L., Yang, M., Teng, A., Ni, C., Wang, P., & Tang, S. (2025). Unraveling Microplastic Effects on Gut Microbiota across Various Animals Using Machine Learning. ACS nano, 19(1), 369–380. https://doi.org/10.1021/acsnano.4c07885

Event

UEG Week Berlin 2025

Topics

Gut Microbiota Colorectal

Submission format

Abstract

Session

The gut ecosystem: From pathogenesis to treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Peter Irving

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

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RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

Partha Pal 1, Kanapuram Pooja 1, Rajesh Gupta 1, Manu Tandan 1, D. Nageshwar Reddy 1

Affiliations

1 Asian Institute of Gastroenterology, Hyderabad, India

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Abstract

Introduction

Although endoscopic balloon dilation (EBD) remains the standard intervention for Crohn’s disease (CD)-associated strictures, its efficacy is limited by high recurrence and surgery rates. Retrospective analyses suggest endoscopic stricturotomy (ES) may offer superior outcomes, particularly in anastomotic strictures. However, no randomized trials have directly compared EBD and ES for short CD-related strictures.

Aims & Methods

This single-center, randomized controlled trial (August 2022–March 2025) enrolled adult CD patients (18–65 years) with symptomatic, predominantly fibrotic or mixed, short strictures (<3 cm), including both de novo and anastomotic types, accessible via standard endoscopy. Patients with multiple (>2) strictures, strictures beyond endoscopic reach, or prior stricturotomy were excluded. Participants were randomized to undergo either EBD or ES. The primary outcome was clinical recurrence at 1 year. Secondary outcomes included re-intervention, surgery, emergency visits, hospitalization, technical success, and adverse events.

Results

Out of 70 randomized patients, 69 were analyzed (EBD: 35; ES: 34). Baseline characteristics were comparable between groups. Technical success was similar (EBD: 91.4%, ES: 94.1%). On time to event analysis, clinical recurrence was significantly lower in the ES group (OR=0.343, 95% CI: 0.134–0.881; p=0.026). Re-intervention rates favored ES (EBD: 25.7%, ES: 8.8%; OR=0.337, 95% CI: 0.131–0.870; p=0.025). Surgery rates were numerically lower with ES (EBD: 11.4%, ES: 5.9%) but not statistically significant (p=0.581). Hospitalization was significantly more frequent in the EBD arm (OR=0.276, 95% CI: 0.091–0.840; p=0.023). ED visits also trended lower with ES, though not statistically significant (p=0.062) (see table). Adverse events occurred in 25.7% of EBD patients (bleeding n=3 [1 hemoclip], pain with admission n=3, micro-perforation n=1, post-procedure pain n=2) and 14.7% of ES patients (bleeding n=3 [1 self-limited, 1 coagrasper, 1 hemoclip], none required transfusion, suspected perforation n=1, mild pain n=1).

Outcome	EBD (n=35)	ES (n=34)	p-value	Odds Ratio (95% CI)
Technical Success (%)	91.4% (32/35)	94.1% (32/34)	0.70	-
Clinical Recurrence (%)	48.6%	23.5%	0.026	0.343 (0.134–0.881)
Re-intervention Rate (%)	25.7%	8.8%	0.025	0.337 (0.131–0.870)
Surgery (%)	11.4%	5.9%	0.581	0.707 (0.207–2.422)
Stricture-related ED Visits (%)	20.0%	11.8%	0.062	0.404 (0.156–1.047)
Stricture-related Hospitalizations (%)	25.7%	8.8%	0.023	0.276 (0.091–0.840)
Any Adverse Event (%)	25.7% (9/35)	14.7% (5/34)	0.45	-

Conclusion

In this interim analysis, ES was associated with significantly lower clinical recurrence, re-intervention, and hospitalization compared to EBD for short CD-related strictures, with similar safety outcomes. These findings support ES as a potentially superior first-line endoscopic strategy over EBD in selected patients with Crohn’s disease strictures. (NCT05521867)

References

Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085. PMID: 29546384.

Event

UEG Week Berlin 2025

Topics

Endoscopy Radiology & Imaging IBD

Submission format

Abstract

Session

Advances in the investigation of the small bowel

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Appendectomy? The solution for ulcerative colitis

Eva Visser

TRANSFORMING IUS INTERPRETATION: INTEGRATION OF AI MODELS IN INTESTINAL ULTRASOUND IMAGING

Oshrit Hoffer

MICROPLASTIC-INDUCED ALTERATIONS IN GUT MICROBIOME AND METABOLISM: INSIGHTS FROM AN EX VIVO BIOREACTOR MODEL

Vanessa Stadlbauer

RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

D. Nageshwar Reddy

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

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Fistulising Crohn's disease: Underlying mechanism

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Fistulising Crohn's disease: Underlying mechanism

Judy Chou 1

Affiliations

1 Icahn School of Medicine at Mount Sinai, New York, United States of America

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Primary Care Surgery

Session

Disease primer: From inflammation to restoration - wound healing in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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D. Nageshwar Reddy

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

UEG Presentation

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ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

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Not sure what you can access? Learn more about account types.

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Krisztina Barbara Gecse 1, Joep van Oostrom 1, Svend T. Rietdijk 2, Svein Oskar Frigstad 3, Glen A Doherty 4, Peter Irving 5, David Laharie 6, Floris de Voogd 1, Maarten Pruijt 1, Suzanne Anjie 1, Lotte Oldenburg 1, Adriaan Volkers 1, Lieven Mulders 1, Rossana de la Croix-Vingerling 2, Renza Koppes 2, Md Monirul Islam 3, Kristin Hammersboen Bjorlykke 7, Kine Haug 7, Carolann Coe 4, Diane Mould 8, John James 8, Chris Moore 9, Melanie Hulshoff 1, Mark Lowenberg 1, Andra Neefjes-Borst 1, Ron Mathôt 1, Esmé Clasquin 1, Kristin Kaasen Jørgensen 10, Sunny Gurm 11, Michael Byrne 11, Geert R. D'Haens 1

Affiliations

1 Amsterdam University Medical Center, Amsterdam, Netherlands

2 Onze Lieven Vrouwen Gasthuis, Amsterdam, Netherlands

3 Vestre Viken HF, Gjettum, Norway

4 University College Dublin, School of Medicine, St Vincent's Hospital, Dublin, Ireland

5 Guy´s and St Thomas´ Hospital, London, United Kingdom

6 Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

7 Akershus Universitetssykehus, Nordbyhagen, Norway

8 Baysient LLC, Fort Meyers, United States

9 BÜHLMANN Laboratories AG, Basel, Switzerland

10 Akershus Universitetssykehus, Faculty of Medicine, University of Oslo, Nordbyhagen, Norway

11 Dova Health Intelligence, Vancouver, Canada

Summary

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Abstract

Introduction

Up to 40% of patients with acute severe ulcerative colitis (ASUC) do not respond to infliximab (IFX)(1) presumably due to insufficient drug exposure (1, 2). We investigated whether personalised IFX induction using predefined serum concentrations was superior to standard dosing.

Aims & Methods

In this prospective, multi-centre trial, adult IFX-naive steroid-refractory ASUC patients were randomised 1:1 to standard (SD) or personalised IFX dosing (PD). After an initial 5 mg/kg IFX infusion, SD was 5 mg/kg IFX at week 2 and 6. In PD, additional 5 mg/kg IFX infusions were administered guided by a Bayesian pharmacokinetic algorithm (iDose™) aiming at IFX serum concentrations >28 ug/mL day 0-28 and >15 ug/mL day 29-42 (3). The primary composite endpoint was clinical and endoscopic response at day 42 (Lichtiger score <10 and ≥3 points drop and UCEIS ≥2 points drop from baseline). Video-endoscopies were performed at baseline, day 42 and 182 and scored by 2 expert readers (XR) with adjudication by a third XR and post hoc also by the DovaVision UC AI tool (AI-R)(4). Key secondary endpoints were day 42 clinical response, day 42 endoscopic response, day 182 clinical remission (Lichtiger ≤3), day 182 endoscopic remission (UCEIS ≤1 on all components), and safety.

Results

48 patients were randomised (23 PD/25 SD) and 31 completed the 26-week study (19 PD/12 SD). Patient characteristics were comparable. Median cumulative IFX dose until day 42 was 18.41 mg/kg [1.77, 20.27] for PD vs 13.79 mg/kg [10.38, 14.82] for SD. The primary composite endpoint at day 42 was not met with XR (57% in PD vs 44% in SD; p=0.564). However, AI-R showed a significantly higher composite response rate in PD (74% in PD vs 32% in SD; p=0.0047). PD showed higher day 42 clinical response vs SD (91% vs 64%; p=0.039). Day 42 endoscopic response was observed in 57% in PD vs 44% in SD (p=0.564) with XR and 74% in PD vs 32% in SD with AI-R (p=0.0047). The proportion of patients in clinical and endoscopic remission at day 182 was higher in PD than in SD (65% vs 36%; p=0.082). Day 182 endoscopic remission with AI-R was higher in PD (52% in PD and 20% in SD; p=0.0337). SAEs occurred in 9% of patients on PD vs 20% of patients on SD. Following an interim analysis, the trial was discontinued based on futility.

Table 1. Baseline characteristics

	Personalised treatment (n=23)	Standard treatment (n=25)
Gender = Male (%)	11 (47.8)	15 (60.0)
Age (year) (median [IQR])	37.00 [24.50, 57.50]	42.00 [30.00, 56.00]
Disease duration (years) (median [IQR])	1.75 [0.62, 5.30]	6.16 [2.61, 17.21]
Naive to advanced therapy (%)	18 (78.3)	21 (84.0)
Lichtiger score (median [IQR])	14 [13, 16]	14 [12, 15]
Total Mayo score (median [IQR])	11 [11, 11]	11 [10, 11]
UCEIS (median [IQR])	6 [5, 7]	6 [5, 7]
CRP (mg/L) (median [IQR])	49.00 [35.70, 70.30]	51.00 [17.00, 105.00]
Albumin (g/L) (median [IQR])	26.00 [23.00, 30.50]	31.00 [23.00, 34.00]

Advanced therapy was defined as treatment with any biologics, JAK inhibitor or S1P modulator. IQR = interquartile range; UCEIS = Ulcerative Colitis Endoscopic Index of Severity, CRP = C-reactive protein.

Conclusion

Personalised IFX dosing was superior to standard dosing in ASUC when endoscopies were read by AI. This is the first IBD study where the primary endpoint, missed by expert assessment, was overturned and met by AI assessment instead. This demonstrates the potential of AI to fundamentally improve clinical trial methodology.

References

1. Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010;59(1):49-54.
2. Papamichael K, Van Stappen T, Vande Casteele N, Gils A, Billiet T, Tops S, et al. Infliximab Concentration Thresholds During Induction Therapy Are Associated With Short-term Mucosal Healing in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2016;14(4):543-9.
3. Ungar B, Mazor Y, Weisshof R, Yanai H, Ron Y, Goren I, et al. Induction infliximab levels among patients with acute severe ulcerative colitis compared with patients with moderately severe ulcerative colitis. Aliment Pharmacol Ther. 2016;43(12):1293-9.
4. Byrne M, Requa J, Panaccione R, Panes J, Bressler B, East JE, et al. Development and Validation of a novel AI-based computer vision solution for Ulcerative Colitis severity scoring on video for real world using high-volume expert-annotated video frames. United European Gastroenterol J. 2025 Oct.

Disclosure

This project received grant support from Pfizer Inc. and research support from Baysient LLC, Buhlmann Laboratories and Dova Health Intelligence.

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD Mechanisms & Personalised Medicine

Submission format

Late-Breaking Abstract

Session

Hot off the press: IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

Appendectomy? The solution for ulcerative colitis

Eva Visser

TRANSFORMING IUS INTERPRETATION: INTEGRATION OF AI MODELS IN INTESTINAL ULTRASOUND IMAGING

Oshrit Hoffer

MICROPLASTIC-INDUCED ALTERATIONS IN GUT MICROBIOME AND METABOLISM: INSIGHTS FROM AN EX VIVO BIOREACTOR MODEL

Vanessa Stadlbauer

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D. Nageshwar Reddy

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving